Suturing device and method for sealing an opening in a blood vessel for other biological structure

ABSTRACT

A suturing device allows a physician to remotely seal an incision in a blood vessel or other biological tissue. The device comprises an elongated tubular body having a distal portion which is adapted to be inserted percutaneously through the incision and into the blood vessel. The distal portion has first and second retractable arms which extend from the distal portion of the body and releasably hold a suture within the blood vessel. First and second retractable needles, each of which is configured to catch the suture from a respective arm, are provided along the body proximal to the retractable arms. The arms and the needles are remotely movable by the physician using a handle or other control mechanism provided at a distal portion of the device. In operation, the arms are initially deployed within the blood vessel to hold the ends of the suture beyond the circumference of the tubular body. The needles are then deployed from and then retracted into the body, during which time the needles pierce the vessel wall on opposite sides of the incision, release the suture ends from the retractable arms, and pull the suture through the vessel wall. The device is particularly useful for closing an incision in an artery following a catheterization procedure. In one embodiment, the catheter sheath introducer (CSI) used to perform the catheterization procedure is left in place during the suturing procedure.

RELATED APPLICATIONS

[0001] This application is a continuation of U.S. application Ser. No.09/773,046 filed Jan. 30, 2001, which is a continuation of U.S.application Ser. No. 09/471,866, filed Dec. 23, 1999, which is acontinuation of U.S. application Ser. No. 09/231,177, filed Jan. 14,1999, now U.S. Pat. No. 6,117,144, which is a continuation-in-part ofU.S. application Ser. No. 09/036,437, filed Mar. 9, 1998, now abandoned,which is a continuation-in-part of application Ser. No. 08/702,315 filedAug. 23, 1996, now U.S. Pat. No. 5,860,990, which claims the benefit ofU.S. Provisional Application No. 60/002,769 filed Aug. 24, 1995.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] The present invention relates to medical suturing devices. Moreparticularly, the present invention relates to suturing devices forclosing an opening in an arterial or other biological tissue wall thatis not directly accessible to the physician.

[0004] 2. Brief Description of the Related Art

[0005] Physicians frequently use sutures to(close cuts, punctures,incisions and other openings in various biological tissue, such as bloodvessels, of the human body.

[0006] In an arterial catheterization procedure, a relatively smallpercutaneous incision is made in the femoral or other artery. A catheteris inserted through the incision and directed along an arterial path toa target area, such as the heart, to perform one or more procedures,such as an angioplasty or angiogram. These procedures are designed to berelatively quick ‘outpatient’ procedures.

[0007] Upon completion of the catheterization procedure, the physiciantypically creates a ‘thrombus patch’ by applying direct pressure to thepatient's thigh to make the blood around the incision clot. Because thefemoral artery must not be completely blocked (occluded) by the appliedpressure, the physician commonly applies direct pressure by hand for thefirst twenty minutes after the procedure. During this time, thephysician can feel the pulse to assure the artery is not occluded.Afterwards, the physician usually turns the procedure over to anassistant who applies direct pressure using sandbags, clamps or otherdevices. A significant problem with this approach is that it isfrequently necessary to apply the pressure for an extended period oftime, such as twenty-four hours or longer.

[0008] Another problem with the thrombus patch method is that the highblood pressure in the artery can cause the thrombus patch to rupture orburst while direct pressure is being applied to the thigh or afterdirect pressure is removed. This requires the whole process to berestarted. If the patch ruptures and is not restored, the patient maybleed to death. Because thrombus patches frequently burst, the patientfrequently must remain in the hospital or catheterization lab overnightfor observation. Thus, these ‘out-patient’ procedures become‘in-patient’ procedures, simply because a thrombus patch it is difficultto create. Staying in the hospital increases patient discomfort andhospital expenses, which are often disproportionate to the actualmedical procedure performed.

[0009] Furthermore, if a thrombus patch cannot be formed, the physicianmay need to anesthetize the patient, occlude blood flow to the artery,make a large incision in the thigh to allow conventional suturing with aneedle, suture the artery with conventional means, restore blood flow tothe artery, and suture the incision in the thigh. This results inadditional discomfort and expenses for the patient.

[0010] While the above problems could potentially be avoided by suturingthe blood vessel immediately following the catherization procedure, thesize and location of the artery make suturing difficult. Specifically,the opening in the thigh is typically too small and too deep to provideenough working space for suturing the artery using conventional methods.Thus, in order to suture the vessel according to conventional methods,the opening in the thigh would have to be significantly enlarged,potentially exposing the patient to additional pain, scarring, andhealth risks.

SUMMARY OF THE INVENTION

[0011] The present invention addresses the above problems by providing asuturing device and method for suturing an opening in a biologicaltissue wall, such as an organ or blood vessel. The device isparticularly well suited to suture an opening made in an artery, such asthe femoral artery, following a catheterization procedure. The deviceeliminates the need to apply pressure to a patient's thigh for anextended period of time, and eliminates many of the complications andcosts associated with the creation of a thrombus patch.

[0012] In a preferred embodiment, the device comprises an elongatedtubular body having a distal portion which is adapted to be insertedpercutaneously through the incision and into the blood vessel. Thedistal portion has first and second retractable arms which extend fromthe distal portion of the body and releasably hold a suture within theblood vessel. First and second retractable needles, each of which isconfigured to catch the suture from a respective arm, are provided alongthe body proximal to the retractable arms. The arms and the needles areremotely movable by the physician using a handle or other controlmechanism provided at a distal portion of the device.

[0013] In operation, the arms are initially deployed within the bloodvessel to hold the ends of the suture beyond the circumference of thetubular body. The needles are then deployed from and then retracted intothe body, during which time the needles pierce the vessel wall onopposite sides of the incision, release and capture the suture ends fromthe retractable arms, and pull the ends of the suture through the vesselwall. The arms are then moved to their retracted position, and thedevice is withdrawn from the blood vessel and the patient's body withthe ends of the suture. A knot or suture clip may then be advanced tothe incision site to close the incision.

[0014] In one embodiment, the arms retract into and extend out from anopening in a distal end of the tubular body. In this embodiment, theelongated body comprises a suture catch assembly which is slidablydeployable along an inner tubular member. In operation the inner tubularmember is initially introduced into the blood vessel through a standardcatheter sheath introducer (CSI), and the CSI is then removed. Thesuture catch assembly is then slidably advanced distally along the innertubular member to the blood vessel, and the needles are deployed topierce the vessel and capture the suture.

[0015] In another embodiment, the arms retract into and extend out fromrespective openings on sides of the tubular body, and the needles extenddistally and outwardly from the elongated body (preferably by flexingoutward during deployment) to capture the suture. In this embodiment,the arms and the suture catch assembly are introduced through the CSI asa unit, and the CSI may be left in the inserted position during thesuturing procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

[0016]FIG. 1A illustrates one embodiment of the present invention in anexemplary use environment.

[0017]FIG. 1B illustrates a cross-sectional view of the device in FIG.1A in an exemplary use environment, such as a patient's thigh.

[0018]FIG. 1C illustrates another embodiment of the present invention inthe exemplary use environment of FIG. 1A.

[0019]FIG. 1D illustrates a cross-sectional view of the device in FIG.1C in an exemplary use environment, such as a human thigh.

[0020]FIG. 2 is a partial cross-sectional view of the suturing devicedepicted in FIG. 1A having a suture catch assembly and a sutureintroducer housing.

[0021]FIG. 3 is a bifurcated perspective view of the suture introducerhousing of FIG. 2.

[0022]FIG. 4 is a partially schematic perspective view of the sutureclasp arms of FIG. 2.

[0023]FIG. 5 is an elevational view of one configuration of a sutureclasp arm.

[0024]FIG. 6 is an elevational view of another configuration of a sutureclasp arm.

[0025]FIG. 7 is an enlarged elevational view of one configuration of asuture clasp.

[0026]FIG. 8 is an enlarged elevational view of a suture having bandscrimped thereon.

[0027]FIG. 9 is an enlarged elevational view of another configuration ofa suture clasp.

[0028]FIG. 10 is an elevational view of the suture clasp of FIG. 9illustrating the action of a suture and the suture clasp as the sutureis being removed from the suture clasp.

[0029]FIG. 11A is a cross-sectional top view of one configuration of asuture introducer housing, suture clasp arms, a suture, and a triangularspreader.

[0030]FIG. 11B is a cross-sectional side view of the suture introducerhousing and triangular spreader of FIG. 11A.

[0031]FIGS. 12 and 13 are partial cross-sectional views of anotherconfiguration of a spreader for deploying the suture clasp arms.

[0032]FIG. 14 is a partial cross-sectional view of an alternateconfiguration of the device for deploying the suture clasp arms.

[0033]FIG. 15 is a partial cross-sectional view of an alternateconfiguration of suture clasp arms.

[0034]FIG. 16 is a partial cross-sectional view of the device of FIG. 15illustrating the suture clasp arms in a deployed position.

[0035]FIG. 17 is a bifurcated perspective view of the suture catchassembly of FIG. 2.

[0036]FIG. 18 is a partial cross-sectional view of an alternateconfiguration of the suture catches and the suture clasp arms.

[0037]FIG. 19 is a schematic perspective view of a needle tip and oneconfiguration of a suture catch.

[0038]FIG. 20 is a cross-sectional view of the suture catch of FIG. 19taken along line 19-19 illustrating the position of a suture fittingcaptured by the suture catch.

[0039]FIG. 21 is a cross-sectional top view of the suture catch of FIG.19 taken along line 20-20.

[0040]FIG. 22 is a schematic illustration of another configuration of asuture fitting.

[0041]FIG. 23 is a side view of a suture clasp arm used to hold thesuture fittings of FIGS. 20 and 22.

[0042]FIG. 24 is a rear elevational view of a needle tip with analternate configuration of the suture catch.

[0043]FIG. 25 is a cross-sectional view of the needle tip of FIG. 24taken along line 24-24 of FIG. 24.

[0044]FIG. 26 is a partial cross-sectional side view of an alternateconfiguration of a suture clasp arm to hold a suture fitting.

[0045]FIG. 27 is an end view of the suture clasp arm of FIG. 26.

[0046]FIG. 28 is a perspective view of a three-sector arm actuatorassembly with a catch in a distal position.

[0047]FIG. 29 is a perspective view of a button of the assembly of FIG.28.

[0048]FIG. 30 is a perspective view of a guide of the assembly of FIG.28.

[0049]FIG. 31 is a perspective view of the catch of the assembly of FIG.28.

[0050]FIG. 32 is a perspective view of the assembly of FIG. 28 with thecatch in a proximal position.

[0051]FIG. 33 is a schematic partial cross-sectional view of theassembly of FIG. 28 with the catch in a distal position.

[0052]FIG. 34 is a partial cross-sectional view of the suture introducerhousing of FIG. 2 with the introducer over the housing.

[0053]FIG. 35 is a partial cross-sectional view of the suture introducerhousing of FIG. 2 with the suture clasp arms deployed.

[0054]FIG. 36 is a partial cross-sectional view of the suture introducerhousing and suture catch assembly of FIG. 2 illustrating the operationof the suture catch assembly.

[0055]FIG. 37 is a partial cross-sectional view of the suture introducerhousing and the suture catch assembly of FIG. 2.

[0056]FIG. 38 is a schematic view of a vessel illustrating the locationof the suture.

[0057]FIG. 39 is a schematic cross-sectional view of the vessel of FIG.38 taken along line 40-40.

[0058]FIG. 40 is a partial schematic cross-sectional view of oneconfiguration of the suturing device having a detachable arm deploymenthandle.

[0059]FIG. 41 is a cross-sectional view of the embodiment depicted inFIG. 1C with the distal end inserted through an arterial wall.

[0060]FIG. 42 is a cross-sectional view of the device of FIG. 41 withthe suture clasp member partially deployed.

[0061]FIG. 43A is a perspective view of a suture clasp member, anactuator and a hollow elongated body of FIG. 41.

[0062]FIG. 43B is an exploded view of the suture clasp member, pivot pinand actuator of FIG. 42.

[0063]FIG. 43C is a perspective view of a two-piece suture clasp member.

[0064]FIG. 43D is a cross-sectional view of the two-piece suture claspmember of FIG. 43C and a spreader within the suture introducer head ofFIG. 41.

[0065]FIG. 44 is a perspective view of the suture introducer head andsuture clasp member of FIG. 41.

[0066]FIG. 45 is perspective view of the device of FIG. 44 with thesuture clasp member partially deployed.

[0067]FIG. 46 is a rear perspective view of the device of FIG. 44.

[0068]FIG. 47 is cross-sectional view of the device of FIG. 41 with thesuture clasp member fully deployed.

[0069]FIG. 48 is a cross-sectional view of another embodiment of thepresent invention.

[0070]FIG. 49 is a cross-sectional view of one embodiment of a handleattached to the proximal end of the device of FIG. 41, the device ofFIG. 48 or the device of FIG. 52A.

[0071]FIG. 50 is a perspective view of the handle of FIG. 49.

[0072]FIG. 51 is a cross-sectional view of another embodiment of ahandle attached to the proximal end of the device of FIG. 41, the deviceof FIG. 48 or the device of FIG. 52A.

[0073]FIG. 52A is a perspective view of the suture introducer head andthe hollow elongated body of FIG. 41 with another embodiment of thesuture clasp arms.

[0074]FIG. 52B is a cross-sectional view of the device of FIG. 52A.

[0075] FIGS. 53A-53B are perspective views of one configuration of thesuture clasp member of FIG. 52A.

[0076]FIG. 54 is a perspective view of the device of FIG. 52A with thesuture clasp member partially deployed.

[0077]FIG. 55 is a perspective view of the device of FIG. 52A with thesuture clasp member fully deployed.

[0078]FIG. 56 is a perspective view of the device of FIG. 52A with thesuture clasp member fully deployed and needles engaging the suture claspmember.

[0079]FIG. 57 is a perspective view of the handle of FIG. 49.

[0080] FIGS. 58-59 are perspective views of a four-arm suture claspmember used with the device of FIGS. 1C-1D.

[0081]FIG. 60 is an exploded view of another handle configurationattached to the proximal end of the device of FIG. 41, the device ofFIG. 48 or the device of FIG. 52A.

[0082]FIG. 61 is a perspective view of the handle of FIG. 60.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0083] The present invention provides a suturing device for suturingbiological tissue. The suturing device may be used to seal a bloodvessel following an interventional catheterization procedure, such as anangiogram. FIGS. 1A-1B illustrate one embodiment of the presentinvention in an exemplary use environment. As depicted by FIGS. 1A-1B,the physician makes an initial incision 20 in the upper thigh 12 of apatient 2. The physician then inserts a needle (not shown) into theincision 20. When blood bleeds back from the insertion, the physicianknows the needle has pierced the femoral artery 16. The physician theninserts a guidewire (not shown) through the needle and into the artery.The physician may take the needle out and insert a plastic needle (notshown) over the guidewire once the guidewire is in place. The guidewiremay then be taken out.

[0084] With this needle in place, the physician can insert a cathetersheath introducer (CSI) 6, also called an introducer sheath. Thisintroducer sheath 6 is typically a single lumen catheter with a valve onits proximal end. The valve is used to prevent extraneous bleed back orto introduce medication into the patient's body. The vessel incision 26provides access for medical instruments and probes inside the arterialvessel 16. Instruments may be inserted into artery 16 via the introducersheath 6 to perform various procedures in the body.

[0085] In FIG. 1A, the suture assembly 4 consists of the suture catchassembly 36 (described below), the suture introducer housing 24, and theintroducer sheath 6. FIG. 1B illustrates a cross-sectional view of thedevice depicted in FIG. 1A in an exemplary use environment, such as apatient's thigh. After the medical procedure described above, thephysician withdraws the CSI 6 and inserts the suture catch assembly 36and the suture introducer housing 24 through the first incision 20. Thesuture catch assembly 36 and suture introducer housing 24 pass throughthe flesh 14 of the patient's thigh 12 and through the second incision26 into the femoral artery 16. In another method, the physician mayfirst insert the suture introducer housing 24, remove the CSI 6, andthen insert the suture catch assembly 36.

[0086]FIGS. 1C and 1D illustrate another embodiment of the presentinvention in the exemplary use environment of FIG. 1A. Unlike the deviceillustrated in FIGS. 1A-1B, the device illustrated in FIGS. 1C-1D doesnot require the removal of the CSI 6 in order for the device to deploy asuture. Several embodiments of the device shown in FIGS. 1A and 1B willnow be described with reference to FIGS. 2-40. The device depicted inFIGS. 1C-1D will thereafter be described in further detail below withreference to FIGS. 41-50.

[0087] Embodiments of FIGS. 1A-1B and 2-40

[0088]FIG. 2 shows one embodiment of the suturing device for suturingvessel walls and other biological tissue. Preferably, the device is foruse in suturing arterial vessel walls 22. However, the device could beused to suture other tissue such as a patent ductus arteriosus, a patentforamen ovale, a heart defect, a puncture wound, and the like. Thesuturing device comprises a suture introducer housing 24 for insertioninto an opening 26 in the arterial wall 22.

[0089] Suture clasp arms 28, 30 are deployably housed in the housing 24during insertion. After insertion into the vessel 16, the arms 28, 30are deployed to the position shown in FIG. 2. When deployed, the sutureclasp arms 28, 30 extend outside the circumference of the sutureintroducer housing 24. Each arm has at least one suture clasp 32,schematically illustrated, for clasping a suture 40. A penetratingmechanism, generally designated 34, is provided for penetrating thevessel wall 22. The penetrating mechanism 34 is provided on either thesuture introducer housing 24 or on a suture catch assembly, generallydesignated 36. When, as shown in FIG. 2, the penetrating mechanism 34 ispart of the suture catch assembly 36, the penetrating mechanism 34 alsocomprises suture catches 38 for catching the suture 40 and dislodging itfrom the suture clasps 32. The suture catch assembly 36 operates to pullthe suture 40 held by the suture catches 38 through the vessel wall 22.After the ends of the suture 40 are pulled outside the vessel wall 22,the introducing housing 22 can be removed and the suture 40 tied toclose the vessel opening 26.

[0090]FIG. 3 shows one configuration where the suture introducer housing24 is a generally cylindrical and thin walled hypo tube. The term “hypotube” is used to describe a hollow elongated cylindrical member with athin wall such that the inner diameter and outer diameter vary by arelatively small amount in the range of few thousandths of an inch totens of thousandths of an inch. The outer surface 42 of the housing 24comprises a key way groove 44 (exaggerated for clarity) to align thehousing 24 with a key 46 (FIG. 17) on the inner surface 48 of the suturecatch assembly 36. An arm actuation assembly 170, to be described below,for deploying the suture clasp arms 28, 30 protrudes from the proximalend of the housing 24, and an actuating wire or rod 50 extends from theactuation assembly 170 through the housing 24 to the suture clasp arms28, 30.

[0091]FIG. 2 shows one configuration where the suture clasp arms 28, 30are attached to the distal end 54 of the actuating rod 50. In thisconfiguration, the arms 28, 30 are pivotally attached to the actuatingrod 50 and pivot around pivot shaft 56. The suture 40 is held inside thehousing 24 and is positioned underneath the spreader 102, so that it canbe removed from the entire housing 24. The arms 28, 30, which are shownin more detail in FIG. 3, terminate with the suture clasps 32(schematically illustrated). Each arm 28, 30 has an elongated body 58which attaches to the pivot shaft 56 at one end and to the suture clasp32 at the other. The length of the body 58 controls how far beyond thecircumference of the suture introducer housing 24 the arms 28, 30 extendwhen they are deployed by the actuating rod 50.

[0092]FIG. 5 shows an alternate configuration of the arms 28, 30. InFIG. 5, the arms 28, 30 are Y-shaped with an offset body 64, and thereis a suture clasp at each tip 60, 62 of the Y-shaped arm. The body 64 isoff center from the tips 66, 68, so that a complimentary arm can pivoton the same pivot shaft 56 without interference. Thus, the Y-shape ofthe arms allows them to pivot beside each other outwardly from andinwardly to their undeployed position without interference from theother arm. The Y-shape of the arm also provides an open area or suturecatch receiving area 80 into which the suture catch 30 fits to catch thesuture 40. Other arm shapes such as the h-shaped arm shown in FIG. 6 mayprovide the same or additional benefits. The h-shaped arm has a body 70with an aperture 71 for attachment to a pivot shaft 56 and each tip 72,74 of the arm is provided with a suture clasp. The body of the h-shapedarm is positioned all the way to the side of the arm and functionssimilarly to the Y-shaped arm. The configuration of the suture clasp armshown in FIG. 6 also has a suture catch receiving area 80A.

[0093]FIGS. 7 and 8 illustrate one configuration of the suture clasp 32,which comprises a key hole shaped slot 76 which widens toward the end ofthe tip to receive the suture 40. As illustrated in FIG. 4, a loop 78 istied in each end of the suture 40. The loop 78 is sized to fit tightlybetween the suture clasps 32 on each arm 28, 30. The key hole shapedslot 76 is elongated and narrows away from the end of the tip 60 to aneck 82 having a width W. The end 84 of the slot 76 is circular with adiameter greater than the neck width W. The diameter of the circular end84 of the slot 76 is sized to receive either the outer diameter of asuture 40, shown in FIG. 8, or the outer diameter of cylindrical bands86 which are crimped onto the suture 40. The suture 40 or the bands 86have an outer diameter approximately the same size as the diameter ofthe end of the slot 76 but smaller than the neck width W. Because thediameter of the bands 86 (or suture 40) is smaller than the width of theneck 83, the bands 86 snap into the end of the slot 76 and are securelyheld therein until removed by the suture catch 38. In an alternateconfiguration (FIG. 14), it is desirable for the slots 76 to openupwardly when they are in the deployed position, so that the suture 40is pulled straight up out of the slots 76.

[0094]FIG. 9 shows another configuration of the suture clasps 32. Inthis configuration, the arm 28, 30 comprises a shaft 88 extending to aplate or bar 90. A resilient element 92, such as a spring, is attachedat each end of the bar 90, and tips 94 are attached to the end of eachresilient member 92. The tips 94 have slots as previously described andshown by FIG. 7. The suture 40 has beads 96 fixed thereto or knots tiedtherein. The beads are spaced apart by a distance just less than thedistance between the outer edges 98 of the tips 94. With this distancebetween the beads 96, the tips 94 must be slightly bent toward eachother thereby loading the resilient members 92 to receive the suture 40.When the tips 94 are pulled inwardly and the resilient members 92loaded, the suture 40 is held in place by the force from the resilientmembers 92. Therefore, the suture 40 is held in tension between the tips94.

[0095] When the suture catch 38 is guided through the suture catchreceiving area 100, the resilient members 92 are further deformed as thesuture 40 is forced to make an arc to receive the suture catch 38 asillustrated in FIG. 10. The resilient members 92 then bend in thedirection that the suture catch 38 is retracted, so that the suture 40slides smoothly out of the clasp 32. If desired, the outer edges 98 ofthe tips may be indented 99 to receive and more securely hold the beads96 or knots on the suture 40.

[0096]FIG. 14 illustrates an alternate configuration of the suture claspslot. The slot 127 opens upwardly toward the penetrating mechanisminstead of transverse to the penetrating mechanism as in the previousconfiguration.

[0097] In FIG. 2, the suture clasp arms 28, 30 are deployed when theactuation rod 50 forces the arms 28, 30 downward to a triangularspreader 102. FIG. 11A is a cross-sectional top view of oneconfiguration of the suture introducer housing 24, the clasp arms 28,30, the suture 40, and a triangular spreader 102. FIG. 11A shows thetriangular spreader 102 extending across a diameter line of the sutureintroducer housing 24. The spreader 102 may be shaped in alternativeforms other than a triangle.

[0098]FIG. 11B is a side view of one configuration of the sutureintroducer housing 24, the triangular spreader 102 and the direction ofthe clasp arms 28, 30 as they extend downward into the blood vessel 16.One vertex 104 of the triangular spreader 102 is positioned centrally inthe housing 24 and extends upwardly. The triangle is preferablyisosceles with respect to the upward extending vertex 104, so that thearms 28, 30 spread uniformly when they engage the spreader 102 and pivotabout the pivot shaft 56. Each arm 28,30 ultimately extends the samedistance beyond the circumference of the housing 24. The surfaces of thespreader 102 and arms 28, 30 which engage to deploy the arms arepreferably smooth, so that the deployment of the arms 28, 30 is smooth.

[0099] Another configuration for deploying the suture clasp arms isshown in FIGS. 12 and 13. The arms 106 are pivotally attached to theactuating rod 50 with a pivot shaft 109, and a circular spreader bar 108or cam pin extending across a diameter line of the housing 110. When theactuating rod 50 forces the suture clasp arms 106 to engage the circularspreader 108, they are forced into the deployed position of FIG. 13. Toobtain smooth deployment of the arms 106, the bottom surface 107 of thearms 106 forms a curved camming surface for engaging the circularspreader 108. The housing 110 has two slit shaped openings 112 evenlyspaced around the circumference of the housing 110 through which thearms 106 extend into the deployed position. The end of the openings 112also forms a stop 113 to prevent the arms 106 from moving past thedeployed position. With the openings 112 in the housing 110, the shapeof the arms 106 is simplified. Because the arms 106 do not have to curvedown out of the housing 110, the arms 106 are straighter than in theprevious configurations.

[0100] An alternative means for deploying the clasp arms is illustratedin FIG. 14. Each clasp arm comprises an upper lever arm 114 pivotallyattached at one end to the actuating rod 50 with a pivot shaft 116 and alower pivot arm 118 pivotally attached to the other end of the upperlever arm 114. The lower pivot arm 118 rotates around a pivot shaftspreader 120 which is attached to the housing 122 and extends across adiameter line of the housing 122. When the actuating rod 50 is forceddistally farther down the housing 122, the lower pivot arms 118 areforced to pivot around the pivot shaft spreader 120, and the arms 118are deployed to the position shown in solid lines. As the lower pivotarm 118 rotates, the upper lever arm 114 rotates relative to the pivotshaft 116, and the junction 124 between the upper and lower arms istranslated downward (distally) and outwardly toward the circumference ofthe housing. When the actuating rod 50 is retracted from the housing,the junction is moved upward and centrally in the housing 122, and thelower pivot arm 118 is rotated to the retracted position shown inpartial dashed lines.

[0101] The housing 122, similar to the configuration of FIG. 13, hasslit openings 126. The openings 126 extend a greater distance along thelength of the housing 122 than in FIG. 13 to allow room for the lowerpivot arm 118 to exit the housing 122 and provide sufficient room forthe junction 124 to move outwardly.

[0102] A stop 129 attached to the upper lever arm 114 is placed betweenthe upper lever arm 114 and the lower pivot arm 118 to prevent the armsfrom moving past the deployed position. Alternatively, the stop 129 canbe inherent in the lower pivot arm 118 and upper lever arm 114. Thiswould include a notch on the side of one of the arms which the other armwould contact to limit the movement of the arms.

[0103]FIG. 14 illustrates the use of a sealing member 52 inside thesuture introducer housing 24. The sealing member 52 prevents blood flowback through the housing 122.

[0104] Still another configuration of the clasp arm deployment mechanismis illustrated in FIGS. 15 and 16. In this configuration, a singleresilient arm 128 is attached to the actuating rod 50. The resilient arm128 is predisposed in a deployed configuration shown in FIG. 16. Whenthe arm 128 is retracted into the housing 24, the prongs 130 of the arm128 are elastically deformed inwardly. When the arm 128 is moved out ofthe housing 24 by the actuating rod 50, the prongs 130 expand to thepredisposed deployed position. This configuration is easily adaptable tohaving four prongs 130 spaced at ninety degrees. Thus, any configurationand number of prongs can be incorporated into the device depending onthe specific needs of the application.

[0105]FIGS. 2 and 17 illustrate a preferred configuration of the suturecatch assembly 36 with a generally cylindrical outer tube 132, which, asdescribed above, includes a key 46 to mate with the key way groove 44 ofthe suture introducer housing 24. The inner diameter of the tube 132 issized to fit over the outer diameter of the suture introducer housing 24without any interference. This fit does not need to be tight because thesuture catch assembly 36 is not inserted into the opening 26 of thevessel 16. Therefore, there is no need to prevent the flow of bloodbetween the suture housing 24 and the suture catch assembly 36. Also,the fit between the suture catch assembly 36 and the suture introducerhousing 24 does need to be close enough to assure that the suture catch38 is properly aligned with respect to the suture clasps 32. Properalignment is accomplished by a close fit between the key 46 and the keyway groove 44.

[0106] The catch assembly 36 comprises a plurality of, preferably two,apertures 134 for slidably receiving respective needles 136 or otherpenetration members. The apertures 134 extend through the length of thetube 132 and may be equally spaced around the circumference of the tube132 in one configuration of the device.

[0107] The blunt ends 138 of the needles 136 are connected to anactivation ring 140, and springs 142 are interposed between theactivation ring and the tube 132. The springs 142 hold the needles in aretracted position so that the needle points are within the tube 132.With the needles 136 biased in a retracted position by the springs, thesuture catch assembly 36 can be handled without the chance of inflictingan unintentional puncture wound.

[0108] At least one stop 144 is fixed on the inner surface 48 of thetube 132 and engages the top 146 of the suture housing 24 to fix therelative position between the suture housing 24 and the catch assembly36. Because the spring 142 can only be compressed a certain distance,the depth of entry of the needles 136 into the vessel 16 is controlledto prevent puncturing the opposite side of the vessel 16. Furthermore,the fixed relative position between the suture housing 24 and catchassembly 36 assures that the needles 136 pass far enough into the suturecatch receiving area 80 to catch the suture 40.

[0109] Near the end of each needle 136 is the suture catch 38. Thesuture catch 38 is an aperture extending to the outer edge on one sideof the needle 136. The aperture is slot shaped and angled upwardlytoward the proximal end of the device. While the needles are beingpulled from the vessel 16, the suture 40 is pulled to the bottom of thesuture catch 38 where it cannot come loose.

[0110]FIG. 18 shows an alternate configuration of a penetratingmechanism, generally designated 150, with the suture introducer housing152. The penetrating mechanism comprises needle points 154 press fitonto arms 156. The end of the arms 156 opposite the needle points 154are fixed to the actuating rod 50. The arms 156 are made of a resilientmaterial exhibiting shape memory such as NITENOL, and the arms 156 areat rest in a deployed position shown in dashed lines. When the arms 156are within the suture housing 152, they are deformed to fit within thehousing 152. When the actuating rod 50 pushes the needle points 154beyond the suture housing, the arms 156 return to their at-rest positionwith the needle points 154 beyond the circumference of the housing 152.The suture 40 is attached to the needle points 154. The needle points154 are then pulled upward by the actuating rod 50 toward the vesselwall 22, thereby penetrating the vessel wall 22 from within the vessel16.

[0111] The suture catch 158 has a V-shaped notch 160 with rounded tips162. There is a slit 164 extending up from the vertex of the notch 160.The rounded tips 162 prevent the suture catch 158 from inadvertentlypuncturing the vessel wall 22. The needle points 154 fit into thenotches 160 and cause the notches 160 to open farther along the slits164. After the needle points 154 are inside a cavity 166 within thesuture catch 158, the notch 160 collapses to its original shape andtraps the needle points 154 inside. The suture catch 158 is then pulledproximally until the press fit between the needle points 154 and thearms 156 is overcome, and the needle points 154 are separated from thearms 156. The actuation rod 50 is then moved proximally to pull the arms156 both into the housing 152.

[0112] For this configuration, an alignment mechanism can be providedsuch as the key way described above. But in the configuration shown, thenotch is circumferential. Thus, no alignment mechanism is needed, andany number of arms 156 extending from the actuating rod can be provided.

[0113] The suture catch 158 can be positioned over an introducer 168 ifdesired. If the proximal end of the introducer 168 is too large for thesuture catch 158 to fit over, the suture catch 158 could be made of aflexible material with a longitudinal slit over its entire lengthallowing it to be expanded to fit around the diameter of the introducer168. The arms 156 would be modified so that the needle points 154 extendbeyond the circumference of the introducer 168.

[0114]FIGS. 19 through 23 illustrate an alternate configuration of thesuture catch and suture clasp. A needle 400 is provided with a slottedopening 402 having a peg 404 extending from the top of the opening 402through a portion thereof. The peg 404 has a narrow and rounded frontpeg surface 406 with an identical radial location on the needle 400 asthe outer surface of the needle 400. The back peg surface 408 of theneedle 400 is relatively wide, rounded, and located toward the radialcenter of the needle 400. The peg sides 410 are flat and angled relativeto the walls 412 of the slotted opening 402. The slotted opening 402receives suture fitting 414 having a shaft 416 connected, preferably bycrimping, to the suture 40 and an enlarged termination 418 which ispreferably spherical.

[0115] The alternate suture fitting 420 of FIG. 22 has a half sphericaltermination 422 with rounded edges. The half spherical termination 422does not protrude beyond the diameter of the needle 400. This halfspherical termination 422 reduces the trauma to the vessel wall 22 whenthe needle 400 is retracted. The shaft in either configuration has alength short enough not to protrude from the diameter of the needle 400when the suture fitting is held by the needle 400. This also reducestrauma to the vessel wall 22 during retraction.

[0116] The suture fitting 414 is held by a modified suture clasp arm 424having an aperture 426 to receive the shaft 416 of the suture fitting414. The wall 428 of the aperture is slowly tapered so that the diameterdecreases as the aperture 426 moves inwardly in the arm 424. Thisfrustoconical shape provides a secure press fit with the suture fittingshaft 416. Other aperture shapes are possible so long as the press fitis secure and is of a force which can be overcome by the retraction ofthe arm 424. The shaft 416 of the suture fittings can also be tapered tobetter mate with the aperture 426.

[0117] When the suture clasp arm 424 is deployed, the termination 418,422 engages the peg 404 forcing it to one side allowing the termination418, 422 to slide against the peg 404 until the termination 418, 422 ispast the peg 404. When the termination 418, 422 slides past the peg 404,the peg 404 snaps toward its at rest central position thereby capturingthe termination 418, 422 and hence the suture 40. When the suture clasparm 424 is retracted, the press fit is overcome and the suture fitting414 is pulled from the arm 424. When the peg 404 snaps back into itscentral position, it tends to pull the suture fitting 414 away from thesuture clasp arm 424. This can be utilized to help overcome the pressfit. With the suture filling securely held, the needles are retracted,the suture fittings 414 cut from the suture 40, and the suture 40 tied.

[0118]FIGS. 24 and 25 illustrate another configuration of the suturecatch. A needle 450 is provided with a slot shaped opening 451 with aU-shaped raised portion 452 in the lower front of the slot 451. Theopening 451 also defines a suture fitting receiving area 454 at the topof the opening 451 for receiving a suture fitting 456 and a suturefitting catch area 458 in the lower back of the slot adjoining theraised portion 452. The suture fitting 456 has a spherical tip 459, andan arcuate neck 460 which tapers down to a cylindrical shaft 462. Thespherical tip 459 is sized to fit through the suture fitting receivingarea 454 but not through the U-shaped raised potion 452. Thus, theraised portion 452 holds the suture fitting 456 in the suture fittingcatch area 458. The raised portion 452 angles toward the back of theneedle 450, so that it becomes larger as it extends farther down theneedle 450.

[0119]FIGS. 26 and 27 show another configuration of the suture clasparms 464, which comprises an upwardly facing key hole shaped opening 466for holding the suture fitting 456. The opening 466 faces upwardly, thatis in the direction of needle retraction, to aid in the removal of thesuture fitting 456 from the suture clasp arm 464.

[0120] In operation, the suture catch is activated to penetrate thetissue to be sutured. The suture clasp arms 464 are deployed directingthe suture fitting 456 into the suture fitting receiving area 454. Asthe suture catch needle 450 is retracted, the neck 460 of the suturefitting 456 is engaged by the raised portion 452, and the angled surfaceof the raised portion 452 pulls the suture fitting 456 farther andfarther toward the back of the needle. Thus, the suture fitting 456 isbeing pulled out of the suture clasp arm 464 as the needle 450 isretracted. If the suture fitting 456 is not completely removed from thesuture clasp arm 464 when it contacts the bottom of the opening 451, itis snapped upwardly pass a neck 468 of the key hole opening 466 and outof the suture clasp arm 464.

[0121] The control of the distal and proximal translation of theactuating rod 50 is preferably performed by the three sector, armactuator assembly, generally designated 170, which is attached to thesuture introducer housing 24 (see FIG. 3). Each sector of the armactuator assembly 170 is substantially identical. FIGS. 28-31 show thatthe arm actuator handle is comprised of three pieces: a button 172, acylindrical guide 174, and a catch 176.

[0122] The button 172 comprises an actuation post 178 extendingcentrally from a closed end of a cylindrical body 180. The cylindricalbody 180 is sized to longitudinally slide in the guide 174. Three buttontabs 182 are spaced equally around the outer surface of the cylindricalbody at the end opposite the actuation post 178. Thus, there is onebutton tab 182 in each sector.

[0123] The catch 176 comprises three catch tabs 184 corresponding to thethree button tabs 182, a cylindrical body 186 which is sized to fitrotatably inside the cylindrical body 180 of the button 172, and acontrol ring 188 at an end of the cylindrical body 186 for engaging thethree button tabs 182. The control ring 188 is at the end of the catch176 corresponding to the end of the button 172 having the button tabs182, and the catch tabs 184 which rotate from sector to sector extendradially from the central ring 188.

[0124] The guide 174, which is attached at its proximal end to, thehousing, has three channels 190 and three notches 192, and the guide 174is open at both ends; so that the button 172 protrudes from the proximalend, and the catch 176 can extend from the opposite (distal) end. Thereis one channel 190 in each sector with a notch 192 adjacent thereto. Thebutton tabs 182 and the catch tabs 184 are slidable within the channels190, each button tab 182 stays in the same channel 190 while each catchtabs 184 is rotated from a channel 190 to a notch 192 and to anotherchannel 190 during operation.

[0125] As indicated, the outer diameter of the button 172 is sized toslide inside the guide 174. Preferably, there is a button gap 194between the button 172 and the guide 174. The diameter of the controlring 188 is sized to rotate freely within the guide 174 with minimumclearance, and the catch cylindrical body 186 is sized to rotate andslide longitudinally inside the button cylindrical body 180 with minimumclearance. This leaves a relatively large catch gap 196 between thecatch cylindrical body 186 and the guide 174. Therefore, the length ofthe catch cylindrical body 186 is preferably long enough so that it isnever withdrawn from the button cylindrical body 180 during operation.

[0126] Because there is a button gap 194 between the button cylindricalbody 180 and the guide 174, the button tabs 182 have a thicknesssufficient to extend across the gap 194 and into the channels 190. Thus,the button tabs 182 also overlap the diameter of the control ring 188,so that the button tabs 182 can engage the control ring 188. The bottomsurface 195 of the button 172 is contoured to mate with the control ring188. The catch tabs 184 have a diameter and thickness so that they slidein the channels 190 and fit into the notches 192. Preferably, the outerdiameter of the guide 174 is the largest diameter thereby assuringadequate clearance for translation of the button 172 and catch tabs 184.

[0127] In FIGS. 28, 32, and 33, the catch 176 starts out in a proximalposition with the catch tabs 184 in the channels 190 as shown in FIG.32. A rotation spring 198 is held in compression between fixed plate200, which is attached to the housing 24, and the catch 176. Therotation spring 198 biases the catch 176 in the proximal direction,which corresponds to a retracted suture clasp arm position.

[0128] The physician presses down on the actuation post 178 of thebutton 172 causing the button tabs 182 to move distally pressing againstthe catch tabs 184 and control ring 188 thereby moving the catch tabs184 distally until the catch tabs 184 are beyond the distal edge 203 ofthe channels 190. At this point, the catch 176 rotates in the directionof arrow 202 in FIG. 32. The rotation is created by the rotation spring198 pushing a top angled surface 204 of the catch tab 184 against thebottom angled surface 206 of the button tabs 182. As the catch 176rotates, it also translates upwardly because of the angled surfaces.This prevents the catch 176 from rotating past the notch 192.

[0129] The physician then releases the actuation post 178 allowing therotation spring 198 to push the catch tabs 184 against the angled notchsurface 208 and rotate the catch tabs 184 until they contact thevertical notch stops 210 as illustrated in FIG. 28. In this rotationalposition, V-shaped depressions 212 on the control ring 188 are alignedwith the channels 190 of the guide 174. When the catch tabs 184 are inthe notches 192, the suture clasp arms 28, 30 are in a deployedposition.

[0130] To retract the needles 136, the physician again depresses theactuating post 178, so that the button tabs 182 engage the V-shapeddepressions 212 in the control ring 188 located between the catch tabs184. This pushes the catch tabs 184 below the bottom of the guide 174.The rotation spring 198 pushing upward on the guide 174 causes the slidesurface 214 of the V-shaped depression 212 to slide across the bottomsurface of the button tab 182 causing the catch tabs 184 to rotate andmove upwardly until they engage the angled bottom return surfaces 216 ofthe guide 174. After the physician releases the actuation post 178, therotation spring 198 continues to force the catch tab 184 to slide overthe return surface 216 until the catch tab 184 reaches the channel 190and the spring 198 forces the catch tab 184 upwardly into the channel190 thereby retracting the suture clasp arms 28, 30. As shown in FIG.33, a button spring 218 can be provided between the catch 176 and thebutton 172 to return the button 172 to an upward position after it isreleased. If the button spring 218 is used, the button tabs 182 contactthe tops of the channels 190 preventing the button 172 from coming offthe assembly.

[0131] The suture clasp arms 28, 30 are completely deployed when thecatch tab 184 is in the notch 192 against the notch stop 210. For theoperation of the actuator assembly, the catch tab 184 is pushed belowthis level several times. To prevent the arms 28, 30 from going past afully deployed position, a resilient member 220 is placed in theactuating rod 50. Once the suture clasp arms 28, 30 reach the fullydeployed position, their further motion is restricted as describedabove. As the catch tab 184 is pushed below the position correspondingto the fully deployed position, the resilient member 220 is compressedallowing the catch tab 184 to be moved the rest of the way below thebottom surface of the guide so that it can rotate to the next position.This prevents damage to the spreader 102, bending the actuating rod 50,and risk of injury to the vessel 16.

[0132] To allow the catch 176 to begin rotating after it clears thebottom of the channel 190 or the bottom of the vertical notch stop 210.The vertex 222 of the button tab 182 is not aligned with the bottom ofthe V-shaped depression 212 when the V-shaped depression 212 is alignedwith the channel 190. The vertex of the depressions 212 is positioned toa side of the vertex of the button tab 182 in the rotational direction,so that the catch 176 is allowed to rotate until it is underneath theshallow end of the return surface 216 of the guide 174. Similarly, whenthe catch tab 184 is inside the channel 190, the angled surfaces 224 ofthe control ring 188 corresponding to the catch tab 184 continue pastthe catch tabs 184 to again allow initial rotation of the catch 176until the catch tab 184 is beneath the shallow end of the notch surface.Thus, the catch tab 184 can rotate underneath the shallow end of thenotch 192 before the button tabs 182 contact the lowest point of thecontrol ring surfaces 224 and rotation is restricted. When the rotationis restricted, the actuation post 178 is released raising the button tab182 out of the way, and the catch 176 can complete its rotation.

[0133] The operation of the device is illustrated in sequence by FIGS.1, 2 and 34 through 36. After the medical procedure, the introducersheath 6 is left in place, and the suture introducer housing 24 isinserted into the introducer 6 and introduced into the artery 16 asshown in FIGS. 1A and 1B. The actuation post 178 is then depressed, asillustrated by arrow 240 in FIG. 35 to deploy the suture clasp arms 28,30 outwardly as illustrated by arrows 242 so that portions, preferablythe ends, are positioned on opposite sides of the opening 26 with thesuture 40 extending transverse to the flow of blood.

[0134] The introducer 6 is then removed, leaving the suture introducerhousing 24 with the suture clasp arms 28, 30 deployed inside the artery16. The opening 26 in the vessel 16 closes around the housing 24 afterthe introducer 6 is removed. In FIG. 38, the suture introducer housing24 is then oriented so that the arms 28, 30 extend transversely to theflow of blood through the vessel 16 which is illustrated by arrow 244.The suture catch assembly 36 is then inserted over the housing 24 andthe stop 144 is brought into contact with the top 146 of the housing 24as shown in FIG. 2. A physician depresses the activation ring 140 asillustrated by arrows 246 (FIG. 36) pushing the needles 136 through thevessel wall 22 and puncturing holes 248 in the vessel wall 22. Thesuture catch 38 catches the suture 40, and the suture catch assembly 36is pulled proximally as illustrated by arrows 250 (FIG. 37). The needles136 can be retracted inside the suture catch assembly 36 or leftdeployed. The suture 40 is cut from the suture catch 38 and pulled tightto remove it from the housing 24.

[0135] The suture clasp arms 28, 30 are retracted by depressing theactuation post 178 again, and the suture 40 is pulled tightsimultaneously with the housing 24 being pulled out of the artery 16.Alternatively, the length of the actuation post 178 is set to correspondwith the height of the depressed activation ring 140. Thus, when theactivation ring 140 is depressed, the actuation post 178 issimultaneously depressed for the second time thereby retracting the arms28, 30 simultaneously with pulling the suture catch assembly 36proximally.

[0136] With the suture catch 38 removed, the pattern of holes shown inFIGS. 38 and 39 is left. As stated above, the suture 40 closes theartery vessel opening 26 transverse to the flow of blood. This is themost efficient direction to close the opening 26. If additional sutureclasp arms are utilized, it is preferred that they make additional holesaround the circumference of the opening as shown in dashed lines in FIG.38, so that sutures again pull the opening 26 closed in a directiontransverse to the flow of blood.

[0137] The present invention could be similarly used to close a patentductus arteriosus, a patent foramen ovale, a heart defect, a puncturewound in the skin, and other tissues requiring suturing.

[0138] An alternate configuration of the suturing device is shown inFIG. 40. The device comprises a pair of suture clasp arms 270 attachedto the end of an actuating rod 272 in accordance with one of the abovedescribed configurations. The actuating rod extends through a needlecover 274 and slidably through a needle actuator 276 to a suture armdeployment handle 278. Near the deployment handle 278 the actuating rod272 has, a severable junction 279. The junction 279 is threaded or snapfit allowing the actuating rod 272 to be quickly separated and joinedthereby quickly removing or attaching the handle 278 from the remainderof the device. The actuating rod 272 can, in the alternative, have ajunction where it enters the needle cover 274.

[0139] Needles 280 are held near their distal ends by a needle guide 282and pass through a stop 284 that limits the deployment distance of theneedles 280. The needles 280 fixably attaching to the needle actuator276. A spring 286 is interposed between the stop 284 and the needleactuator 276 to bias the needles 280 in a retracted position. A secondstop 288 is fixed to the actuating rod 272 on the opposite side of theneedle actuator 276 to prevent the needles 280 from being pulled out ofthe needle guide 282.

[0140] The actuating rod 272 terminates at a thumb ring 290 separatedfrom the distal end of the suture arm deployment handle 278 by a thumbring spring 292 which biases the thumb ring 290 in a proximal positionwhich corresponds to a retracted position of the suture clasp 270. Thehandle 278 also comprises two finger rings 294, 296 on opposite sides ofthe handle allowing a physician to smoothly overcome the force of thethumb ring spring 292.

[0141] In operation, the distal portion of the device, from the needlecover 274 to the suture clasp arms 270, is inserted into the introducer6 with the handle 278 detached. The introducer 6 is removed and thehandle 278 is attached to the device by connecting the actuating rod272. The thumb ring 290 is pushed distally to deploy the suture clasparms 270. A clip 298 hooks onto a clip ring 300 to lock the suture clasparms 270 in the deployed position.

[0142] The actuating rod 272 includes a resilient member 302 (shownschematically), which functions, as described in the previousconfigurations, to prevent the suture clasp arms 270 from moving pasttheir deployed position. The resilient member 302 can simply comprise aspring, or a spring housing can be provided on one part of the actuationrod 272 to receive a spring and a slidable plunger therein. The plunger,which is provided on the opposite part, slides to a maximum distalposition defined by the spring housing and is biased in that position bythe spring. When the suture clasp arms 270 reach a deployed position,the plunger is then forced into the spring housing, compressing thespring and allowing the upper portion of the actuation rod 272 to traveldistally without forcing the suture clasp arms 270 past a deployedposition or bending the actuation rod 272. A thumb ring stop 304prevents the thumb ring 290 from being pushed beyond a point for whichthe resilient member 302 could compensate.

[0143] With the suture clasp arms 270 deployed, the physician grasps theneedle actuator 276, which has a central curved indented surface 306 tomake it easy to grasp, and pushes the needle actuator 276 distally. Theneedles 280 are pushed into the vessel 16 and catch the suture 40 asdescribed in one of the above configurations. The stop 284 prevents theneedles 280 from penetrating too far and damaging the vessel 16. Thespring 286 pushes the needles 280 back to a retracted position when theneedle actuator 276 is released.

[0144] With the suture 40 held by the needles 280, the thumb ring 290 ispushed in a direction transverse to the length of the actuating rod andaway from the clip 298 as illustrated by arrow 308 to release the clip298 and retract the suture clasp arms 270. The entire device isretracted, the suture 40 cut from the needles 280, and the suture 40tied to close the opening 26. Because the handle 278 is detachable, thehandle 278 could be used in conjunction with the above describedconfigurations. In such a case, the arm actuator assembly would beremoved, and the actuating rod 50 would extend through the top of thehousing 24. The end of the actuating rod 50 would be modified to connectto the handle 278.

[0145] Embodiments of FIGS. 1C-1D and 41-50

[0146] In the embodiments described above, the suture introducer housing24 and the suture catch assembly 36 consist of two separate pieces,wherein the suture catch assembly 36 operatively fits around the sutureintroducer housing 24. As described above with reference to FIGS. 1A-1B,in these embodiments, the physician fully removes the original CSI 6before inserting the suture catch assembly 36 to penetrate the bloodvessel wall and catch the ends of a suture. The removal of the CSI 6 andthe introduction of the suture catch assembly 36 may disturb the flesh14 or enlarge the incision 20 and add to the complexity of theprocedure.

[0147] The embodiments illustrated in FIGS. 1C-1D and 41-50, however, donot require the full removal of the original CSI 6 (used for theoriginal percutaneous approach procedure, such as anangioplasty/angiography procedure) in order for the device to catch theends of a suture. Rather, as depicted in FIG. 41, the distal portion ofthe device 520 passes through the CSI 6 and the flesh 14 of thepatient's thigh 12 with minimal disturbance to the flesh 14, and throughthe second incision 26 into the femoral artery 16. Any disturbance tothe flesh 14 is significantly reduced because the CSI 6 is not removedand a suture catch assembly is not slid down over a suture introducerhousing through the flesh 14, as in the embodiments described above withreference to FIGS. 1A-1B and 2-40.

[0148] FIGS. 41-48 illustrate the device 520 depicted in FIGS. 1C-1Dwhere the suture introducer housing and the suture catch assembly areintegrated into a single suture insertion and retraction device 520.This suturing device 520 may comprise a one-piece suture insertion andretraction housing 515 as shown in FIG. 48, or may comprise a sutureintroducer head 522 attached to the distal end of a hollow elongatedbody 514 as shown in FIG. 41.

[0149] With reference to FIG. 41, the suture introducer head 522 and thehollow body 514 are narrower in diameter than the configurationsillustrated in FIGS. 1A-1B and 2-40 because the suture clasp member 500and the needles 546 reside in the same longitudinal space. In otherwords, the needles 546 share the same housing as the suture clasp member500 (while they are all in their retracted state), but are higher up(proximally) in the suturing device 520 than the suture clasp member500. An important feature of this embodiment is that it uses flexibleneedles 546 which bend outward, away from the axis of the device 520,when in the extended position (as shown in FIG. 47).

[0150] The dimensions of the suturing device 520 may vary according tothe suture site and the biological tissue intended to be sutured. In oneconfiguration, the diameter of the suture head introducer 522 is about0.105 inches, and the diameter of the hollow elongated body 514 is about0.098 inches.

[0151] As shown in FIGS. 42, 46 and 47, the suture introducer head 522has two needle ports or apertures 510 formed therein (one per needle546) proximal to the suture clasp arms 524. Each needle port includes aneedle guiding portion 512 (“needle guide”), in the form of an outwardlycurved groove or channel, which guides the corresponding needle 546along a particular path. The needle guides 512 may be formed within thesuture introducer head 522 (as shown in FIG. 41) as part of a mold, ormay be separate pieces (not shown) that are inserted into the sutureintroducer head 522 during manufacture.

[0152] Another advantage of the embodiments illustrated in FIGS. 41-48is the required size of the initial incision 20 into the patient's bodyand the diameter of the introducer sheath 6 used to insert the device520 may be reduced. The size of the suture device 520 may vary dependingon the application and the size of the vessel incision 26.

[0153]FIG. 46 shows a preferred configuration of the hollow elongatedbody 514 with five lumens. Two of the lumens 516 are used to house theneedles 546 (FIG. 41). Another lumen 530 is used to house the actuatingrod 50. Another lumen 532 is used to hold the length of the suture 40 toprevent the suture 40 from becoming tangled. Alternatively, the suture40 may be stored in the actuating rod lumen or in a hole drilled intothe suture clasp arm 500.

[0154] The fifth lumen 534 is preferably used for ‘bleed back,’ whichlets the physician determine whether the distal end 504 of the sutureintroducer head 522 is still positioned in the artery 16 after thephysician removes the catheter sheath introducer (CSI) 6. Bleed back isaccomplished by the hole 540 (FIG. 45) at the distal end 504 of thesuture introducer head 522, the suture clasp arm apertures 508 and anyother openings in the suture introducer head 522. The direction of bloodflow for bleed back is shown by the dashed arrows in FIGS. 41 and 48. Ifthe distal end 504 of the introducer head 522 is still in the artery 16,the blood pressure measured by the blood coming up into the hole 540will be much greater than if the distal end 504 is not in the artery 16.In one embodiment, the bleed back lumen 534 extends to a port (notshown) at a proximal portion of the device, and the physician canobserve the blood pressure through bleed back lumen 534 by monitoringblood flow from the port. For example, the bleed back lumen may beattached to a balloon which inflates when the distal portion 504 of thesuture introducer head 522 is within the blood vessel 16. In anotherembodiment, a pressure sensor is associated with the blood flow lumen534 to provide the physician with a numeric reading. Alternatively, thefifth lumen; 534 may be used to inject medication or for diagnosticpurposes.

[0155] In a preferred embodiment, two thin stripes 538 (only one shownin FIG. 46) are marked on the exterior of the elongated body 514 whichdenote the circumferential location of the two needles 546. Thesestripes extend along a portion of the elongated body 514 which isoutside the patient's body. These stripes help the physician to alignthe needles 546 with the axis of the blood vessel 16, so that the needleincisions 248 (FIG. 47) will be longitudinally aligned. As describedabove for FIG. 38, the suture 40 closes the artery vessel opening 26transverse to the flow of blood. This is the most efficient direction toclose the opening 26. Proper insertion of the needles 546 reduces therisk of damage to the vessel walls 22, 506. Alternatively, there may beonly one stripe to denote the circumferential location of one of the twoneedles 546. The physician will know the circumferential location of theother needle 546 because the needles 546 are 180 degrees apart.

[0156] As illustrated in FIG. 46, the exterior surface of the elongatedbody 514 includes a marker 539 which denotes the proximal position towhich the CSI 6 should be partially withdrawn (after the distal portionof the suturing device 520 has been inserted into the blood vessel 16)to expose the needle apertures 510. The partial withdrawal of the CSI 6is described below. The marker 539 is shown as a visual marker, but mayadditionally or alternatively be in the form of a ridge, groove, orother physical structure which interacts with a corresponding structureof the CSI to allow the physician to position the CSI using the sense offeel. For example, the CSI 6 and elongated body 514 could be configuredto releasably engage or interlock with one another when the CSI reachesthe proper position along the body 514. A specially formed CSI whichincludes such an interlocking structure is included within the scope ofthe invention. One or more additional longitudinal markers (not shown)could be provided along the body 514, distal to marker 539, to indicateother relative positions of the CSI and the body 514, such as theposition at which the retractable arms 524 are exposed outside the CSI.

[0157] As illustrated in FIGS. 41-43, the device 520 includes a single,resilient suture clasp member 500 attached to the actuating rod 50. Thisresilient suture clasp member 500 is preferably of a unitaryconstruction as shown. The suture clasp member 500 comprises a center orhinge portion 542 and two suture clasp arms 524 (one for each needle546). Each suture clasp arm 524 has a suture clasp 544 at the endthereof.

[0158] The hinge portion 542 of the suture clasp member 500 acts as a“living hinge” because it has a memory which causes the member 500 toreturn to a partially open, unretracted position (FIG. 42) when a force(applied via rod 50) is released. This can be seen in FIGS. 41 and 42.In FIG. 42, the suture clasp member 500 is deployed in the artery 16 inits predisposed (relaxed or natural) position. In FIG. 41, the sutureclasp member 500 is retracted into the suture introducer head 522 in itscompressed (stressed or tensed) position. The arms 524 are moved to theretracted position by applying a distal force to the actuator rod 50,which causes the arms to contact deflection surfaces 518 (FIG. 42).

[0159] This suture clasp member 500 is preferably composed of aresilient shape memory material such as NITENOL. The suture clasp member500 may alternatively be composed of another material with spring-likecharacteristics, such as plastic, spring steel, stainless steel or anyvariations thereof. Further, the suture clasp member 500 could becomposed of two arms that are hingedly connected to the actuating rod 50without the use of a resilient hinge, as shown in FIGS. 43C and 43D anddescribed below.

[0160] The living hinge configuration is easily adaptable to havingthree arms spaced at 120 degrees or four arms (as in FIGS. 58 and 59)spaced at ninety degrees. If there are three arms, then there arepreferably 3 needles 546 and six lumens in the elongated body 514. Thus,other configurations and numbers of arms can be incorporated into thedevice to accomplish the specific needs of the application.

[0161] The needles 546 are flexible and preferably made from a materialwith shape memory, such as SUPERFLEX NITENOL. Alternatively, the needles546 may be composed of spring steel, surgical stainless steel or anyvariation thereof. The diameter of the needles 546 is preferably about0.019 inches, but needles with other diameters may be used in accordancewith the present invention.

[0162] When the needles 546 are advanced distally and come in contactwith the needle insertion guides 512, the needle insertion guides causethe needles 546 to bend radially outward. The needles 546 alsopreferably further bend slightly (radially outward) when they come incontact with the angled surfaces 545 of the suture clasp arms 524, asshown in FIG. 47. When the needles 546 are retracted into the needlelumens 516, they resume a straight configuration as a result of theirresiliency. Although the embodiment of FIGS. 41-48 preferably usesflexible needles which bend during deployment, it is contemplated thatnon-bending needled, which may be either straight or curved, couldalternatively be used.

[0163] As illustrated by the cut-away views of FIGS. 43A and 43B, theactuating rod 50 attaches to the resilient suture clasp member 500 by apivot pin 502. The actuating rod 50 in this configuration preferablycomprises a single shaft (as shown), but may comprise a plurality ofshafts in other configurations.

[0164]FIG. 43C is a perspective view of a non-living hinge embodiment ora two-piece suture clasp member 501. FIG. 43D is a cross-sectional viewof the two-piece suture clasp member 501 and a ramp or spreader 523within the suture introducer head 522. Alternatively, the hinge portionof the suture clasp arms 525, 525′ with suture clasps 544 may be similarto a hinge portion shown in FIG. 53, which is described below. Thespreader 523 may be a separate piece attached within the sutureintroducer head 522. Alternatively, the spreader and suture introducerhead 522 may comprise a single molded piece.

[0165] The length of the suture clasp arm 525 is preferably about 0.174inches. The length of both of the suture clasp arms 525, 525′ togetherin their fully extended position (deployed with both arms parallel toeach other) is preferably about 0.288 inches. In other configurations ofthe suture clasp arms 525, 525′, the dimensions may vary.

[0166] In FIG. 43D, when the actuating rod 50 pulls the two-piece sutureclasp member 501 proximally (while the suture clasp member 501 is in itsretracted position), the distal edges of the spreader 523 come incontact with the tips of the suture clasp arms 525, 525′. The spreader523 causes the two suture clasps arms 525, 525′ to open radially outwardrelative to the actuating rod 50. In a preferred method of operation,the actuating rod 50 continues to pull the suture clasp member 501proximally until the center of the suture clasp member 501 fits into thecenter of the spreader 523. To retract the suture clasp arms 525, 525′into the suture clasp member's retracted position, the actuating rod 50is advanced distally, and the interior edges 518 of introducer head 522come in contact with the suture clasp arms 525, 525.′ The interior edges518 of introducer head 522 cause the two suture clasp arms 525, 525′ toretract radially inward relative to the actuating rod 50. The generaluse and operation of the two-piece suture clasp member 501 is similar tothe use and operation of the suture clasp member 500 shown in FIG. 43A,as described below.

[0167] The proximal portion of the suturing device 520 preferablyincludes a handle which allows the physician to externally operate thesuture clasp arms 524 and the needles 546 inside the blood vessel 16.This handle preferably has three actions: a first action in which theactuating rod 50 applies a proximal force to the hinge portion 542 todeploy and maintain the arms 524 in a fully outward position (FIG. 47);a second action to advance the needles 546 distally (FIG. 47) and pullthe needles 546 back proximally using one or more springs; and a thirdaction in which the actuating rod 50 applies a distal force to the hingeportion 542 to retract the arms 524 (FIG. 41 or 48).

[0168] Alternatively, the handle may be a 2-action handle in which oneof the two actions is a combination of two of the three actionsdescribed above for the 3-action handle. For example, in a first action,the actuating rod 50 applies a proximal force to the hinge portion 542to deploy and maintain the suture clasp arms 524 in a fully extendedstate of FIG. 47. With the arms 524 in this fully extended position, theneedles 546 automatically advance distally (FIG. 47) and retractproximally to capture the looped ends of the suture 40. In a secondaction for this 2-action handle, the actuating rod 50 applies a distalforce to the hinge portion 542 to retract the arms 524 (FIG. 41 or 48).This 2-action handle is suited for physicians with more experience inoperating this suture device 520. It will be apparent to one of ordinaryskill in the art that a 1-action handle or a 4-action handle (insertingand withdrawing the needles 546 as two separate actions) could be used,or that separate handles or triggers could be provided for differentactions.

[0169]FIG. 49 is a cross-sectional view of one embodiment of a handle550 operatively attached to the proximal end of the hollow elongatedbody 514 of FIG. 41 or the single suture insertion and retractionhousing 515 of FIG. 48 or the device of FIG. 52A. FIG. 50 is aperspective view of the handle 550. FIG. 57 is a perspective view of thehandle 550 of FIG. 49. The handle 550 comprises an actuating rodaperture 551, a main housing 552, a pair of finger grips 554, a sutureclasp arm piston 556 with a locking groove 576, a needle piston 560 withat least one raised key portion 562, a releasor 568 with a lockingstopper 572, a pivot pin 570, a releasor support 574, a compressionspring (not shown) operatively positioned in a spring recess 578 betweenthe suture clasp arm piston 556 and the needle piston 560, a needlepiston support cylinder 580 with at least one grooved recess 564 andneedle clamps 584.

[0170] In one configuration, the housing 552 is attached to or is acontinuation of the hollow elongated body 514 of FIG. 41 or the singlesuture insertion and retraction housing 515 of FIG. 48. In anotherconfiguration, the housing 552 is separate from the hollow elongatedbody 514 or single suture insertion and retraction housing 515. In thisconfiguration, the actuating rod 50 connects the housing 552 with thehollow elongated body 514 or single suture insertion and retractionhousing 515.

[0171] A proximal portion of the actuating rod 50 (FIGS. 41 and 48)slides through the actuating rod aperture 551 at the distal end of thehousing 552. The proximal end of the actuating rod 50 is attached to thedistal end 558 of the suture clasp arm piston 556, which is slidablyreceived within the main housing 552. A compression spring (not shown)resides in the spring recess 578 of the housing 552 between the sutureclasp arm piston 556 and the needle piston 560 and simultaneously exertstwo forces: a distal force on the suture clasp arm piston 556; and aproximal force on the needle piston 560.

[0172] The needle clamps 584 of the needle piston 560 hold the proximalends of the needles 546. The needle piston 560 is slidably receivedwithin a distal portion of the housing 552. The needle piston supportcylinder 580 is attached to the housing 552 and preferably does not moverelative to the housing 552.

[0173] The releasor 568 pivots radially inward and outward on the pivotpin 570. The releasor support 574 exerts a radially outward force on thereleasor 568. This force causes the releasor 568 to pivot and thelocking stopper 572 to fall into the locking groove 576 of the sutureclasp arm piston 556 when the locking groove 576 is aligned to receivethe locking stopper 572. The releasor support 574 is preferably made ofa resilient shape memory material such as NITENOL. The releasor support574 may alternatively be composed of another material with spring-likecharacteristics, such as plastic, spring steel, stainless steel orvariations thereof. Other embodiments of the handle are described belowwith reference to FIGS. 57, 60 and 61.

[0174] The use and operation of the device 520 and the handle 550 willnow be described with reference to FIGS. 1C-1D and 41-50. In operation,with the CSI extending into the patient's artery 16, the physicianinserts the suture introducer head 522 through a catheter sheathintroducer (CSI) 6 and into the artery 16 (FIGS. 1C-1D). The CSI 6 isthen partially withdrawn along the body 514 of the suturing device 520to remove the CSI 6 from the artery 16 and expose the needle apertures510, as shown in FIG. 41. There are one or more markings 539 (FIG. 46)on the exterior surface of the elongated body 514 which indicate how farthe physician should withdraw the CSI 6 to expose the needle apertures510.

[0175] The distal end 504 of the introducer head 522 has a smooth,rounded surface to prevent injury to the opposite vessel wall 506 wheninserting the introducer head 522. In addition, the blood flow in theartery 16 is uninterrupted because the introducer head 522 does notocclude the artery 16. The physician may use the aperture 540 at thedistal end of the suture introducer head 522 and the bleed back lumen534 to determine when the distal end 504 of the suture introducer head522 is in the artery 16.

[0176] While the introducer head 522 is inserted into the artery 16 inFIG. 41, the actuating rod 50 holds the resilient suture clasp member500 in its compressed position within the introducer head 522. Theactuating rod 50 applies a downward force while the interior edges 518of the introducer head 522 apply an inward force on the two suture clasparms 524. The combination of these two forces cause the hinge portion542 of suture clasp member 500 between the two arms 524 to elasticallydeform or compress. The suture clasps 544 hold the looped ends of asuture 40 in the angled slot of the suture clasps 544 as shown in FIGS.41-43A. The looped ends of the suture 40 are held securely by the sutureclasps but are positioned for easy removal by the suture catches 38 ofthe needles 546.

[0177] When the distal portion of the device 520 (FIGS. 41 and 48) isproperly positioned in the blood vessel 16, the physician may deploy thesuture clasp arms 524 (FIGS. 42) by pulling the finger grips 554 in aproximal direction relative to the housing 552 (FIG. 50). A physicianmay pull the suture clasp arm piston 556 proximally by placing thephysician's index and middle finger around the finger grips 554 andpushing on the proximal end 582 of the housing 552. This action issimilar to operating a standard syringe. This motion compresses thespring (not shown) in the spring recess 578 of the handle 550 in aproximal direction. As the suture clasp arm piston 556 moves proximally,the actuating rod 50 moves in a proximal direction relative to theelongated body 514 or housing 515. This is shown by the arrows in FIG.42. This motion causes the suture clasp member 500 to deploy or open toits predisposed or natural position as shown in FIG. 42. The sutureclasp arms 524 deploy out of the introducer head 522 into the bloodvessel 16 through two suture clasp arm apertures 508 (FIG. 42), one oneither side of the introducer head 522.

[0178] When the physician pulls the suture clasp arm piston 556 acertain proximal distance relative to the housing 552, the lockingstopper 572 at the distal end of the releasor 568 moves radially inwardand falls into the locking groove 576 of the piston 556. The lockingstopper 572, in combination with the locking groove 576, prevents thesuture clasp arm piston 556 from advancing distally. The force of thespring in recess 578 prevents the suture clasp arm piston 556 frommoving proximally. The locking of the suture clasp arm piston 556stabilizes the suture clasp arms 524 in a locked position before theneedles 546 are advanced distally.

[0179] In this locked position, the suture clasp arms 524 preferablyhave reached their fully extended position, as shown in FIG. 47. In thefully extended position, the actuating rod 50 (attached to the sutureclasp arm piston 556) has pulled the resilient suture clasp member 500up, and the proximal inside edges 536 of the aperture 508 have come incontact with the arms 524 of the suture clasp member 500. This is shownin FIG. 47. The pulling of the actuating rod 50 and the stationaryinside edges 536 of the apertures 508 cause the arms 524 to bendbackward until the arms 524 are longitudinally aligned with each other,as shown in FIG. 47. Thus, the resilient suture clasp member 500 isdeformed from its natural configuration again, but this time in anextended position instead of a compressed position. In this extendedposition, the physician may move the suturing device 520 proximally sothat the arms 524 touch the interior of the vessel wall 22 while theneedles 546 advance distally and capture the ends of the suture 40 fromthe suture clasps 544.

[0180] Next, the physician twists the needle piston 560 clockwise orcounter-clockwise until the raised key portion 562 of the needle piston560 matches the grooved recess 564 of the needle piston support cylinder580. The grooved recess 564 of the needle piston support cylinder 580allows the raised key portion 562 of the needle piston 560 to advancedistally. Otherwise, the needle piston 560 may not be advanced distallyif the raised key portion 562 does not match the grooved access 564. Theneedle piston support cylinder 580 and the raised key portion 562 of theneedle piston 560 prevent the needles 546 from advancing distallyprematurely or improperly. Premature or improper insertion of theneedles may cause damage to the patient's surrounding tissue 14 (FIGS.1B and 1D) or the blood vessel 16.

[0181] When the raised key portion 562 of the needle piston 560 matchesthe grooved recess 564 of the needle piston support cylinder 580, thephysician may advance the proximal end of the needle piston 560 (withthe physician's thumb or palm) in a distal direction relative to theproximal end 582 of the housing 552. This motion compresses the springin the spring recess 578 in a distal direction. When the needle piston560 advances distally, the needles 546 and the suture catches 38 on theneedles (FIG. 47) also advance distally.

[0182] The paths taken by the needles 546 are illustrated in FIG. 47.The needles 546 slide along the needle housings 516 (or needle lumens)and out of the suture device 520 through needle apertures 510. When theneedles 546 come in contact with the needle insertion guides 512, theneedles 546 begin to bend radially outward. As the needles 546 exit,they are guided at a radially outward, acute angle away from theactuating rod 50 by the needle insertion guides 512. The angle of theneedle deflection is preferably 13.2 degrees. Deflection angles in theranges of 10 to 15 degrees and 5 to 20 degrees are also contemplated.

[0183] The needles 546 then penetrate the vessel wall 22 at an angle bycreating incisions 248 on either side of the main vessel incision 26.The needles 546 also preferably bend slightly (radially outward) whenthey come in contact with the suture clasp arms 524. The combination ofthe suture clasps 544 and the suture catches 38 on the needles 546creates a lock on the looped ends of the suture 40, such that the sutureends will not fall off while the needle 546 engages the suture claspmember 500.

[0184] The physician advances the needle piston 560 distally until theresistance of the compression spring prevents the needle piston 560 fromadvancing any further distally. In this position, the needles 546 aresufficiently advanced in the blood vessel 16 such that when the needles546 are pulled back proximally, the suture catches 38 on the needles 546will catch the looped ends of the suture 40 from the suture clasps 544.As shown in FIG. 47, the clasp arms 524 hold the suture loops away fromthe suture introducer head 522, so that the needles 546 pierce thevessel 22 and catch the suture loops outside the perimeter of the sutureintroducer head 522.

[0185] After the physician advances the needle piston 560 to itsfarthest distal position, the physician releases the needle piston 560.The compressed spring causes the needle piston 560 to immediately springback proximally. This motion causes the distal portion of the needles546 to immediately spring back proximally into the needle housing 516with the looped ends of the suture 40 attached to the suture catches 38.

[0186] The suture catches 38 on the needles 546 catch the suture loopsheld by the suture clasps 544 and pull the ends of the suture 40 upthrough the punctured holes 248 when the needles 546 are retractedproximally. When the needles 546 are retracted into the needle lumens516, they resume a straight configuration. As the needles 546 retract, asegment of the suture 40 is released (as a result of the tension causedby the retracting needles 546) through an aperture 540 at the distal end504 of the suture introducer head 522 and into the artery 16.

[0187] To retract the suture clasp arms 524 (FIG. 41 and 48), thephysician presses the proximal portion of the releasor 568 in a radiallyinward direction. This motion causes the releasor 568 to pivot. Thelocking stopper 572 moves radially outward and releases the lockinggroove 576. The force of the compressed spring causes the suture clasparm piston 556 and the actuating rod 50 to advance distally. Togetherwith the proximal interior edges 518 of the introducer head 522, thedownward force of the actuating rod 50 causes the resilient suture claspmember 500 to retract into its compressed position. As shown in FIGS. 44and 45, the suture clasp arms 524 retract into respective apertures orgrooves 508 on the exterior surface of the introducer head 522. In thisretracted state, the arms 524 are substantially parallel with theelongated body 514. As FIG. 44 illustrates, the exterior surfaces of thearms 524 are flush with the exterior surface of the introducer head 522.This reduces the likelihood that the arms 524 will catch on the vesselwall 22 or flesh 14 during withdrawal. The device 520 is now ready forremoval from the blood vessel 16.

[0188] The physician withdraws the device 520 out of the blood vessel 16and out of the flesh 14 of the patient's thigh 12. After the device 520is withdrawn (and with the CSI 6 still in the flesh 14), the physicianpulls the ends of the suture 40 and closes the main vessel incision 26.The physician then ties at least one knot with the ends of the suture 40and slides or pushes the knot(s) down through the CSI 6 to the vesselincision 26. Alternatively, the physician may fasten a small, circularor flat stainless steel clip (not shown) to the ends of the suture 40and slide the clip down through the CSI 6 to the vessel opening 26 toclose the opening 26. The physician then cuts the unused ends (extralength) of the suture 40 and removes the cut portions. The physicianthen removes the CSI 6 from the patient's thigh 12.

[0189] Some of the advantages of the suturing device 520 shown in FIGS.41-48 will now be described in greater detail. First, the radialdeployment of the suture clasp arms 524 (FIGS. 41-42 and 47) from thesides of the suturing device's body, instead of deployment from thedistal tip, provides an advantage over other embodiments. The device 520shown in FIGS. 41-48 deploys its suture clasp arms 524 in a radialdirection without extending beyond the distal end 504 of the device 520.Thus, this device 520 reduces the likelihood that the suture clasp arms524 will contact and damage the inner vessel wall 506 opposite theincision 26.

[0190] Second, the locked position of the suture clasp arms 524 (asdescribed above with reference to FIG. 47) provides a stable base orfoundation for holding the looped ends of the suture 40 while theneedles 546 come in contact with the suture clasp arms 524 and capturethe suture 40. The suture clasp arms 524 are locked in the lockedposition by the proximal force of the actuating rod 50, the stationaryinside edges 536 of the apertures 508 and the protrusions 528 at the‘elbow’ end of each arm 524 (FIG. 47). Specifically, when the sutureclasp arms 524 become substantially parallel with each other (i.e., eacharm 524 is at an angle of approximately 90 degrees from the actuatingrod 50), the protrusions 528 at the ‘elbow’ end of each arm 524 comeinto contact with each other and prevent the arms 524 from bending anyfurther than the configuration shown in FIG. 47. The suture clasp member500 cannot open any farther, even when the needles 546 are inserteddistally and come in contact with the suture clasp arms 524. Theprotrusions 528 prevent the suture clasp member 500 from movingunintentionally (opening any farther) when the needles 546 come incontact with the suture clasp arms 524. This reduces the risk of thelooped ends of the suture 40 being accidently displaced from the sutureclasps 544 when the needles 546 engage the suture clasps 544. Thus, thecombination of forces asserted by the actuating rod 50, the proximalinside edges 536 of the aperture 508 and the two protrusions 528 sustainthe suture clasp arms 524 in a rigid, locked position to facilitate theproper removal of the suture looped ends from the suture clasps 544.

[0191] Third, the shape and position of the angled slits of the sutureclasps 544 in FIGS. 41-48 provide another advantage. The slits of thesuture clasps 544 in FIGS. 41-48 are angled in a proximal, radiallyinward direction. Thus, the face of the looped ends of the suture 40face in a proximal, radially inward direction. In this configuration,there is less chance of the looped ends of the suture 40 falling off thesuture clasps 544 improperly or prematurely. When the needles 546 engagethe suture clasp arms 524, the only direction the looped ends may moveis in a proximal, radially inward direction, which is in the oppositedirection of the inserted needles 546. When the needles 546 retractproximally (as shown in FIG. 47), the looped ends reliably fall into thesuture catches 38 of the needles 546. It is the proximal movement of theneedles 546 in the embodiments in FIGS. 41-48 which causes the suturecatches 38 on the needles 546 to catch the looped ends of the suture 40.This configuration does not rely on a radially outward tension in thelooped ends to fasten the looped ends onto the suture catches 38 whenthe needles 546 are inserted distally.

[0192] In the various embodiments described with reference to FIGS.1C-1D and 41-48, retractable suture clasp arms are used to hold thesuture 40 beyond the outer circumference of the tubular housing (andthus beyond the boundaries of the incision 26), and flexible needles 546are used to capture the held suture 40 outside the outer circumference.In other implementations (not shown), the suture clasp assembly may bein the form of a fixed (non-moving) member which holds the suture nearor within the circumference of the housing. In such implementations,curved needles may be used which pierce the vessel wall outside thecircumference of the housing and then “curve in” to capture the suture.The curved needles may then be withdrawn to pull the ends of the sutureout of the vessel wall.

[0193]FIG. 51 is a cross-sectional view of another embodiment of ahandle 600 attached to the proximal end of the hollow elongated body 514of FIG. 41 or the single suture insertion and retraction housing 515 ofFIG. 48 or the device of FIG. 52A. The handle 600 of FIG. 51 comprises ahousing 602 with a spring recess 622, a pair of external finger grips604 (only one shown in FIG. 51), a suture clasp arm piston 606 with alocking groove 608, a releasor 612 with a locking head 610 and a needlepiston stopper 618, a pivot pin 614, a needle piston 620 with needleclamps 616 and a spring 624.

[0194] The handle 600 also includes a second spring (not shown) whichbiases the releasor 612 toward,a position in which the locking head 610is engaged with the groove 608. Similar to the handle 550 shown in FIG.50, the finger grips 604 extend outside the housing 602 to allow aphysician to move the piston 606 relative to the housing 602. Theneedles 546 in FIG. 51 are attached to the needle clamps 616, which isattached to the needle piston 620. The actuating rod 50 (FIG. 41) isattached to the suture clasp arm piston 606 in FIG. 51.

[0195] The general operation of the handle 600 shown in FIG. 51 issimilar to the operation of the handle 550 shown in FIGS. 49-50. In FIG.51, the needle piston stopper 618 prevents the needle piston 620 fromdistally advancing prematurely or improperly. This function is similarto the function of the raised key portion 562 and grooved recess 564 ofthe handle 550 shown in FIGS. 49-50. In FIG. 51, the physician advancesthe suture clasp arm piston 606 proximally against the biasing force ofthe spring 614 (by pulling the finger grips 604 proximally) to deploythe suture clasp arms 524 (FIG. 42) until the locking head 610 of thereleasor 612 moves radially inward and falls into the locking groove608. At this point, the clasp arms 524 are in the fully deployed or openposition as in FIG. 47. This motion causes the proximal portion of thereleasor 612 to advance radially outward until the needle piston stopper618 is no longer blocking the needle piston 620. At this time, thephysician may advance the needle piston 620 distally into the recess 622to cause the needles 546 to advance distally and capture the suture 40.When the physician releases the needle piston 620, the spring 614 movesthe needle piston proximally to the outward position, causing theneedles 546 to retract with the suture 40. Finally, the physicianpresses the external lever portion of the releasor 612 to release thesuture clasp arm piston 606; this causes the suture clasp arms 524 toreturn to the retracted position, so that the device can be withdrawnfrom the artery 16.

[0196] One of ordinary skill in the art will appreciate that there aremany possible configurations of this handle attached to the proximal endof the device 520. In one configuration (not shown), there are at leasttwo springs or sets of springs (not shown), instead of the singlecompression spring as used by the handle 550 in FIGS. 49-50 and thehandle 600 in FIG. 51. In this embodiment with two springs, a firstspring exerts a proximal force on the needles 546 while a second springexerts a distal force on the actuating rod 50 inside the handle. Inanother configuration (not shown), instead of a second set of springs ora trigger, the physician manually retracts the needles 546 proximallyback into the needle housing 516. In another configuration, a handle(not shown) attached to the proximal end of the device 520 is similar tothe handle as shown in FIG. 40.

[0197] Embodiments of FIGS. 52A-59.

[0198]FIG. 52A is a perspective view of the suture introducer head 522and the hollow elongated body 514 of FIG. 41 with another embodiment ofthe suture clasp arms 630, 630′. In this embodiment, the ends of thesuture are provided with special loops 41 that are configured to engagewith the needles (as described below). FIG. 52B is a cross-sectionalview of the device of FIG. 52A. FIG. 53A-53B are perspective views ofone configuration of the suture clasp arms 630, 630′ shown in FIG. 52A.FIG. 54 is a perspective view of the device of FIG. 52A with the sutureclasp arms 630, 630′ partially deployed. FIGS. 55-56 are perspectiveviews of the device of FIG. 52A with the suture clasp arms 630, 630′fully deployed. FIG. 56 further shows two flexible needles 650 engagingthe suture clasp arms 630, 630′.

[0199] As shown in FIG. 52A, a first suture clasp arm 630 comprises ahinge portion 636 with an aperture 642 for a pivot pin 502 (FIG. 43C).The first suture clasp arm 630 further comprises a curved portion 638for the distal end of an actuating rod 50 (as in FIG. 43B) and the hingeportion of a second suture clasp arm 630′ (FIG. 53B). The first sutureclasp arm 630 further comprises an annular recess 632 for holding asuture looped end 41, a slit 640 for the length of the suture 40, and asloped end 634. FIG. 53B illustrates the second suture clasp arm 630′,which is the other half of a two-arm suture clasp member. The secondsuture clasp arm 630′ is similar to first suture clasp arm 630 exceptthe second suture clasp arm 630′ does not have a curved portion 638 forthe distal end of an actuating rod 50 (as in FIG. 43B).

[0200] The length of the first suture clasp arm 630 is preferably about0.174 inches. The length of both of the suture clasp arms 630, 630′together in their fully extended position (deployed with both armsparallel to each other) is preferably about 0.288 inches. In otherconfigurations of the suture clasp arms 630, 630′, the dimensions mayvary.

[0201] As shown in FIGS. 55-56, each of the flexible needles 650comprises an extended shaft, a penetrating distal tip 654, and a groove652 near the distal end. The needle groove 652 acts as a detentmechanism or suture catch. In a preferred configuration, the grooves 652extend around the complete circumference of the needles 650. In otherconfigurations, the grooves 652 are partially circumferential along theradial edge of the needles 650. The loops 41 correspond generally indiameter to grooves 652 of the needles 650, but are sufficientlyresilient to expand in diameter in response to the downward force of theneedles 650.

[0202] The looped end 41 of the suture 40 may be formed by heating oneend of a length of suture until the end becomes a ball-shapedconfiguration. The ball-shaped end is then compressed into a disc shape.A hole is then made near the center of the disc-shaped end such that thedisc-shaped end forms a loop. In one configuration, the suture comprisesa monofilament or plastic suture material, such as prolene or declene.In one method of forming the looped end, instead of heating the end of asuture length, the suture end is simply compressed and a hole is formedthereafter. The end may be further cut or stamped into a circle shape.

[0203] In another configuration, instead of pre-forming the hole in thesuture end, the actuation of the needles 650, as described below withreference to FIG. 56, is used to form the hole and fasten the ends ofthe suture to the needles 650.

[0204] In another configuration, a separately-formed loop isinsert-molded, glued, crimped or otherwise attached to the end of alength of suture. The loop may be in the shape of a circle, oval,triangle, rectangle, hexagon, octagon, etc.

[0205] The general use and operation of the suture clasp arms 630, 630′in FIGS. 52A-56 is substantially similar to the use and operation of thesuture clasp arms 524 described above with reference to FIGS. 41-48.Specifically, the looped ends 41 of the suture 40 are placed within theannular recess 632 of the suture clasp arms 630, 630′ (FIGS. 52A and54). The suture introducer head 522 is inserted into biological tissue(similar to FIG. 47), and the suture clasp arms 630, 630′ are deployedradially outward (FIG. 55). The penetrating flexible needles 650 passthrough the biological tissue to be sutured (similar to FIG. 47) andengage the suture clasp arms 630, 630′ (FIG. 56).

[0206] When the needle points 654 pass through the looped ends 41 of thesuture 40, the looped ends 41 flex radially outward momentarily. As theneedles 650 continue to advance distally, the looped ends 41 come incontact with the grooves 652. The looped ends flex radially inward andfasten around the needle grooves 652, such that pulling the needles 650proximally causes the suture ends 41 to follow the proximal movement ofthe needles 650. Thus, the grooves 652 serve the same general purpose asthe suture catches 38 (FIG. 41) described above with reference to FIGS.41-42 and 47.

[0207] FIGS. 58-59 are perspective views of a four-arm suture claspmember used with the device of FIGS. 1C-1D. The device shown in FIGS.58-59 comprises four needle apertures 670 and four suture clasp arms662-668. Each of the four suture clasp arms 662-668 comprises an annularrecess and a slit for the length of the suture. In one embodiment, twosutures are used with the device shown in FIGS. 58-69, each of which isheld by a pair of suture clasp arms. Each suture has a loop at eitherend which is placed within one of annular recesses of a suture clasparm. The arms 662-668 may alternatively be provided with one of theother types of suture clasp structures disclosed herein.

[0208]FIG. 60 is a perspective, exploded view of another handleconfiguration 700 attached to the proximal end of the device of FIG. 41,the device of FIG. 48 or the device of FIG. 52A. FIG. 61 is aperspective view of the handle of FIG. 60. In FIG. 60, the handle 700comprises a thumb ring 702, a plunger 704, a plunger distal end 706, amain housing 710, a proximal aperture 708, a finger ring 712, a slopedfloater peg slot 714, a floater clamp slot 715, a distal end aperture716, a floater 720, a peg 718, a floater clamp lock 722, a floater clamp724, a drive wire (actuating rod 50) clamp 726, a needle holder backer728, a needle holder 730, a floater clamp peg 732, a floater clampaperture 734, a spring 736, a plunger pegs 738, L-shaped lock recess 740and an extrusion (hollow elongated body 514) clamp 742.

[0209] The spring 736, the floater 720, the floater clamp lock 722, thefloater clamp 724, the drive wire clamp 726, the needle holder backer728, the needle holder 730 and the extrusion clamp 732 are operativelyreceived within the main housing 710. The shaft of the plunger 704 isslidably received through the floater 720, the floater clamp lock 722and the floater clamp 724.

[0210] The square- or rectangular-shaped shaft of the plunger 704 fitswithin the square- or rectangular-shaped axial recess of the floater720, such that rotating the plunger 702 clockwise causes the floater 720to rotate clockwise as well. The plunger distal end 706 is adapted tosnap into or otherwise attach itself into the needle holder backer 728.The plunger pegs 738 are slidably received along the L-shaped lockrecess 740 formed on the interior of the main housing 710.

[0211] In a preferred configuration, the L-shaped recess lock 740, thefloater peg slot 714 and the floater clamp slot 715 are all molded,carved or otherwise formed on the interior of the main housing 710. Thespring 736 provides a proximal biasing force on the plunger pegs 738 andthe plunger 704. The spring 736 also provides a distal biasing force onthe floater 720.

[0212] The floater peg 718 is slidably received along the slopingfloater peg slot 714. The distal end of the floater 720 snaps and locksinto the proximal portion of the floater clamp lock 722. The floaterclamp lock 722 is preferably glued, bonded or otherwise attached to thefloater clamp 724. The drive wire clamp 726 fits within the aperture 734of the floater clamp 724. The drive wire clamp 726 is glued, bonded orotherwise attached to a proximal portion of a drive wire or theactuating rod 50 of FIG. 52B.

[0213] The extrusion (hollow elongated body 514) clamp 742 is glued,bonded or otherwise attached to a proximal portion of the hollowelongated body 514 of FIG. 52A. The needle holder 730 is preferablyglued, bonded or otherwise attached to the needle holder backer 728. Theproximal portion of the needles 546 of FIG. 47 or the needles 650 ofFIG. 55 are preferably glued, bonded, molded into or otherwise attachedto the needle holder 730.

[0214] The use and operation of the handle 700 will now be describedwith reference to FIG. 60. While the handle 700 is in its initial stateand shipped to end-users, the plunger pegs 738 within the L-shaped lockrecess 740 prevent the plunger 704 from moving distally relative to themain housing 710. When a physician rotates the plunger 704 clockwise bytwisting the thumb ring 702, the plunger pegs 738 move circumferentiallyalong the L-shaped lock recess until the plunger pegs 738 are positionedto slide distally down the longitudinal part of the L-shaped lock recess740.

[0215] As the physician rotates the plunger 704, the floater 720 alsorotates clockwise. The peg 718 moving within the sloped floater peg slot714 causes the floater 720 to move proximally. Because the drive wireclamp 726 is attached to the drive wire or actuating rod 50 (FIG. 52A),the proximal movement of the floater 720 causes the floater clamp lock722, the floater clamp 724, the drive wire clamp 726, and the actuatingrod 50 to move proximally, such that the suture clasp arms 630, 630′deploy radially outward (FIG. 52A-52B).

[0216] Once the plunger 702 is fully rotated and the plunger pegs 738are positioned to slide distally down the longitudinal part of theL-shaped lock recess 740, the physician may advance the plunger 702distally. The distal movement of the plunger 702 causes the needles 546(FIG. 47) or the needles 650 (FIG. 55) to advance distally, penetratethe biological tissue, and engage the suture clasp arms 524, 630, 630′(FIG. 47 and FIG. 55).

[0217] While embodiments and applications of this invention have beenshown and described, it will be apparent to those skilled in the artthat various modifications are possible without departing from the scopeof the invention. It is, therefore, to be understood that within thescope of the appended claims, this invention may be practiced otherwisethan as specifically described.

What is claimed is:
 1. A suturing apparatus, comprising: an elongatebody; an arm mounted to move relative to said elongate body, said armhaving a suture mounting portion which mounts an end portion of asuture, said arm having a proximal portion and a distal portion, saidarm being mounted to permit said proximal portion to move away from saidbody to a first position and towards said body to a second position; anda needle having a distal end, said needle mounted to move relative tosaid elongate body, said distal end of said needle movable from aposition adjacent said elongate body to a position spaced outwardly fromsaid body and to said suture mounting portion of said arm when said armis in said first position.
 2. The apparatus of claim 1, wherein saiddistal portion is disposed adjacent said body during said movement ofsaid proximal portion.
 3. The apparatus of claim 1, wherein said needlecomprises a shaft portion and a tip portion, and wherein said apparatuscomprises an eyelet disposed in said suture mounting portion, saideyelet sized to receive said distal end of said needle and to engagesaid needle by interference fit.
 4. The apparatus of claim 3, whereinsaid needle comprises a shoulder proximal to the tip portion, saidshoulder sized to capture said eyelet.
 5. A suturing device, comprising:an elongate housing having a proximal end and a distal end; an armmounted to move relative to said elongate body, said arm including asuture mounting portion and being actuatable between a first positionwherein said arm is within said body and a second position wherein saidarm is extended away from said body; and a needle having a distal end,said needle mounted to move longitudinally along at least a portion ofsaid elongate body in a proximal to distal direction and to said suturemounting portion when said arm is in said second position.
 6. Thesuturing device of claim 5, further comprising an actuator within saidhousing for actuating said arm between said first and second positions.7. The suturing device of claim 6, wherein said actuator movesproximally to actuate said arm from said first position to said secondposition.
 8. The suturing device of claim 5, comprising another of saidarms.
 9. The suturing device of claim 8, wherein said arms aresubstantially parallel to one another when said arms are in their secondposition.
 10. The suturing device of claim 9, wherein each of said armsis substantially transverse to the longitudinal axis of the elongatehousing when said arms are in their second position.
 11. The suturingdevice of claim 8, wherein each of said arms is a separate piece.
 12. Asuturing apparatus, comprising: an elongated body; an arm mounted tomove relative to said elongated body, said arm having a suture mountingportion which mounts a portion of a suture, said arm being mounted tomove away from said body to an extended position and towards said bodyto a retracted position; and a needle having a distal end, said needlemounted to move relative to said elongated body, said distal end of saidneedle movable from a position within said elongated body to a positionspaced outwardly from said body and to said suture mounting portion ofsaid arm when said arm is in said extended position, such that saidportion of said suture is engaged by said distal end of said needle. 13.The apparatus of claim 12, wherein said needle comprises a shaft portionand a tip portion, and wherein said suture comprises an eyelet disposedin said suture mounting portion, said eyelet sized to receive saiddistal end of said needle, such that said eyelet is captured by saidneedle.
 14. The apparatus of claim 13, wherein said needle comprises ashoulder proximal to the tip portion, said shoulder sized to capturesaid eyelet.
 15. The apparatus of claim 12, further comprising: a secondarm mounted to move relative to said elongated body, said second armhaving a suture mounting portion which mounts another portion of saidsuture, said second arm being mounted to move away from said body to anextended position and towards said body to a retracted position; and asecond needle having a distal end, said second needle mounted to moverelative to said elongated body, said distal end of said second needlemovable from a position within said elongated body to a position spacedoutwardly from said body and to said suture mounting portion of saidsecond arm when said second arm is in said extended position, such thatsaid another portion of said suture is engaged by said distal end ofsaid second needle.
 16. The apparatus of claim 15, wherein both of saidneedles are configured to move relative to said elongated body at thesame time.
 17. The apparatus of claim 15, wherein said needles areconfigured to move relative to said elongated body at different times.18. The apparatus of claim 17, wherein each of said needles isconfigured to penetrate a first tissue portion and said second needle,respectively, such that said first tissue portion and said second tissueportion are substantially drawn together when said portions of saidsuture are drawn together.
 19. The apparatus of claim 12, wherein saidelongated body is adapted to bend said needle away from said body assaid needle is advanced to penetrate tissue.
 20. The apparatus of claim19, wherein said elongated body comprises a needle guide for bending theneedle.